FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
05/31/1991
Recalls and Field Corrections: May 31, 1991
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
Product: Danny Boy brand Canned Chunk Light Pilchard, in 66-1/2
ounce cans. Recall #F-022-2.
Code: All codes.
Manufacturer: CIA Pesquera Farro, S.A. Chimbote, Peru.
Recalled by: Amerigroup International Corporation, Miami, Florida,
by telephone August 23, 1991. Firm-initiated recall
ongoing.
Distribution: Florida.
Quantity: 915 cases (6 cans per case) were distributed.
Reason: Potential for post processing contamination of leaking
cans with pathogenic organisms.
----
Product: Gulf Coast Fresh Crabmeat in 16 ounce plastic cup.
Recall #F-023-2.
Code: None.
Manufacturer: Gulfcoast Crabmeat, Inc., Panama City, Florida.
Recalled by: Manufacturer, by telephone September 12, 1991. Firm-
initiated recall complete.
Distribution: Maryland.
Quantity: 252 pounds were distributed; firm estimates none remains
on the market.
Reason: Product was contaminated with Listeria monocytogenes.
----
Product: (a) Fancy Dried Apricots, packed in approximately 0.75
pound rigid plastic containers;
(b) Dried Papaya, packed in approximately 0.79 pound
rigid plastic container. Recall #F-034/035-2.
Code: None.
Manufacturer: Linden Distributors, Linden, New Jersey (repacker, out
of business).
Recalled by: Supermarket chain removed product from retail shelves
following notification of problem by New York State
Department of Agriculture and Markets. Firm-initiated
recall complete.
Distribution: New York.
Quantity: FDA estimates none remains on the market.
Reason: Product contained undeclared sulfites.
----
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
Product: Chocolate Covered Lemon Marshmallow Candy, unit weight
1 pound 1-1/2 ounces. Recall #F-012-2.
Code: None.
Manufacturer: Wedel Works, Warsaw, Poland.
Recalled by: Adamba International, Inc., Maspeth, New York, by
telephone. Firm-initiated recall complete.
Distribution: New York, New Jersey.
Quantity: 17 cartons (12 units per carton) were distributed;
firm estimates none remains on the market.
Reason: Product contained undeclared FD&C Yellow No. 5.
----
Product: Eastland Food brand Frozen Coconut Candy, in 7 ounce
clear plastic bags, individually wrapped.
Recall #F-024-2.
Code: Item number on case 167960. Individual packages are
not coded.
Manufacturer: Jack Hong Company, Ltd., Bangkok, Thailand (importer).
Recalled by: Eastland Food Corporation, Columbia, Maryland, by
telephone weekend of September 20, 1991, followed by
letter September 23, 1991. Firm-initiated recall ongoing.
Distribution: States east of the Mississippi River.
Quantity: Undetermined.
Reason: Product is contaminated with salmonella.
----
Product: Jelly Beans Candy named "Minnesota River Rock", in
3 ounce clear plastic bags. Recall #F-026-2.
Code: All product as there is no lot number or catalog number.
Manufacturer: J.B. Sales, Conyers, Georgia.
Recalled by: Manufacturer, by visit June 28, 1991. Firm-initiated
recall ongoing.
Distribution: Minnesota.
Quantity: Firm estimates 120 bags remain on the market.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Product: Dried Pineapple Tidbits, packed in approximately
0.79 pound rigid plastic containers. Recall #F-036-2.
Code: None.
Manufacturer: Linden Distributors, Linden, New Jersey (repacker, out
of business).
Recalled by: Supermarket chain removed product from retail shelves
following notification of problem by New York State
Department of Agriculture and Markets. Firm-initiated
recall complete.
Distribution: New York.
Quantity: FDA estimates none remains on the market.
Reason: Product contained undeclared sulfites.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Breaded Shrimp, frozen, packed in 4 pound boxes 26-30
count. Recall #F-027-2.
Code: Lot numbers 091781 and 091621.
Manufacturer: Lombardi's Seafood, Inc., Orlando, Florida.
Recalled by: Manufacturer, by letter August 8, 1991. Firm-initiated
recall ongoing.
Distribution: Florida.
Quantity: 154 boxes were distributed.
Reason: Product contains excessive breading.
----
Product: Minute Maid Fruit Juice beverages in 9.6 fluid ounce
glass bottles: (a) Apple Juice from concentrate;
(b) Concord Punch; (c) Fruit Punch;
(d) Orange Fruit Juice Blend from concentrate;
(e) Pink Grapefruit Juice Cocktail;
(f) Tropical Punch. Recall #F-028/033-2.
Code: All lots produced March 18 - April 6, 1991 and
July 25-27, 1991. Bottles are contained in cases coded
01S031891 through 48S040691 and 01S072591 through
48S072791.
Manufacturer: The Whitlock Packaging Company, Fort Gibson, Oklahoma.
Recalled by: Coca Cola Foods, a Division of The Coca-Cola Company,
Houston, Texas, by letter September 11, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 174,000 cases (24 bottles per case)
were distributed; firm estimates 15,000 cases
remain on the market.
Reason: Product is contaminated with yeast.
----
Product: Chunk Light Tuna, in 6-1/2 ounce cans under the
Ocean King, IGA, and Blue Bay labels. Recall #F-037-2.
Code: All cans showing a "V" in the 4th position of the top
line and a "T" in the second position of the bottom line.
Manufacturer: Star Kist Foods Canada, Inc., St. Andrews, N.B. Canada.
Recalled by: Ocean King Foods of Delaware, Inc., New York, New York,
by letter September 10, 1991. Firm-initiated recall
ongoing.
Distribution: Wisconsin, New Jersey, Pennsylvania, New York,
Michigan, Rhode Island.
Quantity: Approximately 17,000 cases (48 cans per case) were
distributed.
Reason: Product is decomposed.
----
COSMETICS
Class I -
NONE
Class II -
NONE
Class III -
Product: Frames brand Oxina 20, hydrogen peroxide, in 32 ounce
plastic bottles, used to prepare hair for coloring.
Recall #F-025-2.
Code: Lot numbers: 91306, 91307, 91308.
Manufacturer: Fort Pitt Acquisition, Coraspolis, Pennsylvania.
Recalled by: Manufacturer, by telefax September 25, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 164 cases (12 bottles per case) were distributed.
Reason: Product contains 7.2% instead of 6.0% of hydrogen
peroxide as labeled.
----
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Platelets. Recall #B-028-2.
Code: Unit numbers: 613497, 613530, 613548, 614847, 614850,
614858, 617768, 617776. Recall #B-028-2.
Manufacturer: Belle Bonfils Memorial Center, Denver, Colorado.
Recalled by: Manufacturer, by telephone June 12, 1991.
Firm-initiated recall complete.
Distribution: Colorado.
Quantity: 8 units.
Reason: Blood components were distributed labeled with
incorrect expiration dates.
----
Product: (a) Red Blood Cells; (b) Fresh Frozen Plasma;
(c) Platelets; (d) Recovered Plasma. Recall #B-032/035-2.
Code: Unit numbers: (a) 07G73637, 07G75769, 07G77067, 07G79131,
07L07959, 07G87061, 07G92514, 07J33864;
(b & c) 07G75769, 07G87061, 07G92514, 07J33864;
(d) 07G73637, 07G77067, 07G79131, 07L07959, 07G80013.
Manufacturer: American Red Cross Blood Services, Tucson, Arizona.
Recalled by: Manufacturer, by letter April 18, 1991. Firm-initiated
recall ongoing.
Distribution: Arizona, California, New York.
Quantity: (a) 8 units; (b) 4 units; (c) 4 units; (d) 5 units.
Reason: Blood products, which tested non-reactive for the
hepatitis B surface antigen (HBsAg) but were collected
from a donor with a prior history of hepatitis,
were distributed.
----
Class III -
Product: Red Blood Cells. Recall #B-029-2.
Code: Unit #489458.
Manufacturer: Belle Bonfils Memorial Center, Denver, Colorado.
Recalled by: Manufacturer, by telephone July 18, 1991.
Firm-initiated recall complete.
Distribution: Colorado.
Quantity: 1 unit.
Reason: Blood components were distributed labeled with
incorrect expiration dates.
----
Product: Platelets. Recall #B-030-2.
Code: Unit 97617.
Manufacturer: Lane Memorial Blood Bank, Eugene, Oregon.
Recalled by: April 15, 1991 through routine delivery.
Firm-initiated recall complete.
Distribution: Oregon.
Quantity: 1 unit.
Reason: Blood component, which was untested for hepatitis B
surface antigen (HBsAg), antibody to the human
immunodeficiency virus, type 1 (anti-HIV-1), antibody
to human T lymphotropic virus, type I (anti-HTLV-I),
antibody to hepatitis C virus (anti-HCV), antibody to
hepatitis B core (anti-HBc), alanine amino transferase
(ALT) and RPR, was distributed.
----
Product: (a) Red Blood Cells; (b) Platelets;
(c) Platelets, Pheresis. Recall #B-037/039-2.
Code: Unit numbers: (a) l7028-7542, l7028-7551, l7028-7552,
17028-7871, l7028-7880, l7028-7971, l7028-8264,
17028-8268, 17028-8270, 17028-8273.
(b) l7028-7869, l7028-7874, l7028-7878, l7028-7968,
l7028-7969, 17028-7973, 17028-8275, 17028-8389, 17028-8390;
(c) C0207744.
Manufacturer: United Blood Services, McAllen, Texas.
Recalled by: Manufacturer, by telephone March 25, 1991. Firm-
initiated recall complete.
Distribution: Texas.
Quantity: (a) 10 units; (b) 9 units; (c) 1 unit.
Reason: Blood products, incorrectly tested for the antibody to
the hepatitis C virus (anti-HCV) and the antibody to
the human T-cell lymphotropic virus type I
(anti-HTLV-I), were distributed.
----
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
Product: Orcolon Viscoelastic Gel, in 0.75 ml sterile syringes,
indicated for use as a surgical aid in anterior segment
ocular surgery. Recall #Z-033-2.
Code: All lots.
Manufacturer: Optical Radiation Corporation, Azusa, California.
Recalled by: Manufacturer, by letter October 10, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 57,250 units were distributed; firm estimates 2,000 units
remain on the market.
Reason: Microgel contamination may be contributing to incidents
of delayed intraocular pressure rises which may be
difficult to control medically. Some patients have
required secondary surgical procedures and some have
experienced blindness as a result of the pressure.
----
Class II -
Product: Silicone gel filled breast implants, for use in breast
augmentation, breast reconstruction, and correction
of congenital malformation:
(a) Optimam (polyurethane foam covered);
(b) Meme (polyurethane foam covered);
(c) Vogue (polyurethane foam covered);
(d) Replicon (polyurethane foam covered);
(e) Meme Moderate Profile (polyurethane foam covered);
(f) Natural Y (polyurethane foam covered);
(g) Custom Polyurethane Covered Implants;
(h) Standard Bilumen;
(i) Standard Gel;
(j) Standard Gel/Saline;
(k) Standard Adjustable Reconstructive;
(l) Standard Teardrop Gel (GB Snyder);
(m) Georgaide;
(n) Perras-Papillon;
(o) Special Fills SCL or Standard;
(p) Products larger than 600 cubic centimeters.
Recall #Z-1109/1124-1.
Code: All lot numbers/control numbers and catalog numbers of
the above 14 models.
Manufacturer: Surgitek Mec, Paso Robles, California and Surgitek
Mec, Racine, Wisconsin.
Recalled by: Surgitek Mec, Paso Robles, California, by letter
dated July 9, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: Unknown.
Reason: These silicone gel-filled breast prostheses (SGFBP) were
on the market after July 9, 1991, without a premarket
approval application (PMA), as required by the final rule
of April 10, 1991, pursuant to Section 515(b) of the FD&C
Act.
----
Product: UltraFlex Thin (Polymacon) Soft Contact Lenses, labeled
power -1.50 D, 8.70 base curve, 14.5 diameter.
Recall #Z-041-2.
Code: Lot number 417727 EXP 7/96.
Manufacturer: Lombart Lenses Ltd., Norfolk, Virginia.
Recalled by: Manufacturer, by telephone September 5-6, 1991,
followed by letter September 13, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 278 lenses were distributed.
Reason: The labels incorrectly state " -1.50D" power when the
actual power is " -7.50D".
----
Product: Ultrafast Nephretect Residual Glutaraldehyde and
Formaldehyde Detector. Recall #Z-042-2.
Code: Catalog #5000, lot numbers 2049 through 2052 and
2055 through 2061.
Manufacturer: Alden Scientific Inc., Winthrop, Massachusetts.
Recalled by: Manufacturer, by telephone January 2, 1991 followed
by letter on or about March 1, 1991. Firm-initiated
recall complete.
Distribution: Nationwide.
Quantity: Firm estimates none remains on the market.
Reason: The residual aldehyde detector is subject to premature
color change, due to iron contamination.
----
Product: Advantx X-Ray Systems (a) Model 46-289657;
(b) Model 46-275979; (c) 46-289804. Recall #Z-043/045-2.
Code: All serial numbers.
Manufacturer: G.E. Medical Systems, General Electric Company,
Milwaukee, Wisconsin.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan October 11, 1991. Firm-initiated field
correction ongoing.
Distribution: Nationwide and international.
Quantity: 1,300 systems were distributed.
Reason: Noncompliance with the performance standard for
x-ray products in that they may experience increased
radiation output as the x-ray tube approaches the end of
useful life. The increased radiation output may cause:
(1) the fluoroscopic patient entrance exposure rate to
exceed the limits given in the Federal Performance
Standard for Diagnostic Fluoroscopic Systems, or (2) the
system x-ray tube current to exceed its maximum deviation
from accuracy specifications for short radiographic
exposures.
----
Product: Bicarb Kit 2 Single Treatment Bicarbonate Kit, a Rx
device for use on dialysis patients with moderate
acidosis, packed 20 per case. Recall #Z-048-2.
Code: Lot numbers AF1G098 and AF1H099. Product #35641.
Manufacturer: Organon Teknika, Oklahoma City, Oklahoma.
Recalled by: Manufacturer, by telephone October 8, 1991, followed
by letter October 10, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 400 kits were distributed.
Reason: Some kits contain a 50 gram packet of sodium bicarbonate
(labeled as 50 gram) instead of a 30 gram packet as
labeled on the outer labeling.
----
Product: Multiple brands of 53 different diagnostic x-ray units
which had been refurbished by the recalling firm.
Recall #Z-049-2.
Code: UX1003; UX1004; UX1006; UX1007; UX1010; UX1011; UX1013;
UX1018; UX1020; UX1021; UX1022; UX1027; UX1028; UX1029;
UX1031; UX1032; UX1034; UX1035; UX1036; UX1039; UX1041;
UX1043; UX1045; UX1046; UX1047; UX1049; UX1053; UX1062;
UX1066; UX1067; UX1069; UX1073; UX1074; UX1076; UX1080;
UX1086; UX1092; UX1094; UX1096; UX1098; UX1101; UX1104;
UX1116; UX1125; UX1132; UX1135; UX1136; UX1138; UX1147;
UX1148; UX1150; UX1153; UX1154.
Manufacturer: Multiple firms.
Recalled by: United X-Ray, Inc., Knoxville, Tennessee (refurbisher).
FDA approved the firm's corrective action plan
September 10, 1991. Firm-initiated field correction
ongoing.
Distribution: Colorado, Florida, Georgia, Illinois, Kentucky,
North Carolina, Pennsylvania, South Carolina, Tennessee,
Virginia, West Virginia, Wisconsin.
Quantity: 53 units.
Reason: The subject units were refurbished with non-certified
timers, without testing of the units after installation,
and the firm failed to submit reports of assembly for
the refurbished installed x-ray units in violation of
Subchapter C - Electronic Product Radiation control,
Section 538(a)(1)(4) and (5) of the Federal Food Drug
and Cosmetic Act.
----
Product: Disposable MPR Manual Pulmonary Resuscitator with Oxygen
Reservoir:
(a) Adult catalog numbers 700, 701, 702, 703, 704, 705;
(b) Pediatric Catalog numbers 707, 708, 709, 710;
(c) Infant Catalog numbers 711, 712, 713, 714.
Recall #Z-050/052-2.
Code: Lot numbers 21490 through 21510.
Manufacturer: Hospitak Inc., Lindenhurst, New York.
Recalled by: Manufacturer, by letter July 18, 1989. Firm-initiated
recall ongoing.
Distribution: Nationwide and Canada.
Quantity: (a) 6,367 units; (b) 1,936 units; (c) 1,725 units were
distributed; firm estimates none remains on the market.
Reason: The bottom inlet becomes detached rendering the product
inoperable.
----
Product: Theratron 780C (T780C) Cobalt 60 radiation therapy device.
Recall #Z-053-2.
Code: Serial numbers 1 through 68.
Manufacturer: Theratronics International, Ltd., formerly Atomic Energy
of Canada, Ltd. (AECL Medical), Carrollton, Texas
(assembler of device/importer of components).
Recalled by: Theratronics International, Ltd., Atomic Energy of Canada,
Ltd. (AECL Medical), Kanata, Ontario, Canada, by user
bulletin April 29, 1988. Firm-initiated field correction
ongoing.
Distribution: Oregon, New York, Massachusetts, New Jersey, Ohio,
Texas, and international.
Quantity: 68 units were distributed.
Reason: Unwanted source movement may occur with the treatment
room door closed. Relay k11 may energize in the event
of a short in the device circuitry resulting in the
unwanted source movement.
----
Product: Theratron 780 (T780) and Eldorado 78 (E78) radiation
therapy device. Recall #Z-054-2.
Code: Serial numbers: 1 through 142 for T780 and
1 through 31 for E78.
Manufacturer: Theratronics International, Ltd., formerly Atomic Energy
of Canada, Ltd. (AECL Medical), Carrollton, Texas
(assembler of device/importer of components).
Recalled by: Theratronics International, Ltd., formerly Atomic Energy
of Canada, Ltd. (AECL Medical), Kanata, Ontario, Canada,
by User Bulletin CUB-85-1 dated November 20, 1985.
Firm-initiated field correction ongoing.
Distribution: Nationwide and international.
Quantity: T780 - Firm estimates that 134 of 142 units, distributed
between 1974 and 1985, remain in service.
E78 - Firm estimates that 13 of 31 units, distributed
between 1973 and 1985, remain in service.
Reason: Product design allows the source to be turned on if
certain individual mechanical or electrical components
fail.
----
Product: Therasim 750 and Theratron 780 Cobalt 60 radiation
therapy device. Recall #Z-055-2.
Code: Serial numbers: 1 through 142 (T750); 142 through 291
(T780).
Manufacturer: Theratronics International, Ltd., formerly Atomic Energy
of Canada, Ltd. (AECL Medical), Carrollton, Texas
(assembler of device/importer of components).
Recalled by: Theratronics International, Ltd., formerly Atomic Energy
of Canada, Ltd. (AECL Medical), Kanata, Ontario, Canada,
by User Bulletin CUB-86-1 dated September 22, 1986.
Firm-initiated field correction ongoing.
Distribution: Nationwide and international.
Quantity: T750 - 142 units were distributed beginning in 1975.
Firm estimates that 90 percent of the units remain in
service.
T780 - 150 units were distributed from 1974 through 1985.
Firm estimates that 95 percent of the units remain in
service.
Reason: The ceiling mounted hand control sections may become
loose and fall with continued use.
----
Product: TMA MicroScan Scatterometer Model H-1300-01 Handheld
Measurement Head, used for measurement of reflective
and transmissive optical scattering. Recall #Z-056-2.
Code: Model H-1300-01.
Manufacturer: TMA Technologies, Inc., Bozeman, Montana.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan October 18, 1991. Firm-initiated field
correction complete.
Distribution: Pennsylvania.
Quantity: 1 unit was distributed.
Reason: Noncompliance with the performance standard for laser
product in that the calculated laser radiation levels
exceeded the Class I limits.
----
Product: Vygon brand Umbilical Catheters, 4, 5, 6, 7, and 8 French
size, sterile, packaged in paper. Recall #Z-057-2.
Code: Product code 270. All sizes and lots.
Manufacturer: Demequip Route de Bavay, Frameries, Belgium.
Recalled by: Vygon Corporation, East Rutherford, New Jersey, by
telephone April 30, 1991 - May 3, 1991, followed by
letter. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada, Mexico.
Quantity: 15,275 units were distributed; firm estimates 550
remain on the market.
Reason: The plastic (Diakon) hub cracked after being in contact
with an alcohol based antiseptic, commonly used in
hospitals.
----
Class III -
Product: ASO-PLUS Latex Reagent Kit, an in-vitro diagnostic for
detection of antibodies associated with streptococcal
infections. Recall #Z-047-2.
Code: Kits containing latex reagent with lot numbers
171OR11A1, 1710R11A2, 1710T1A1, 1710T2A1, 1710T3A1.
Manufacturer: Texas Immunology, Inc., Tyler, Texas.
Recalled by: V-Tech, Inc., Pomona, California, by letter
January 10, 1990. Firm-initiated recall ongoing.
Distribution: California.
Quantity: 5,038 kits were distributed; firm estimates none
remains on the market.
Reason: Product may provide inaccurate test results.
----
VETERINARY PRODUCTS
NONE
Medical Device Safety Alerts:
Product: Medtronic 4012 Bipolar Polyurethane Pacemaker Leads.
Safety Alert #M-002-2.
Code: All lots.
Manufacturer: Medtronic, Inc., Minneapolis, Minnesota.
Alerted by: Manufacturer, by letter September 26, 1991 and by
press release.
Distribution: Nationwide and international.
Quantity: 150,000 units were distributed.
Reason: Insulation failure and conductor fracture associated with
"subclavian crush." Failure of the lead may result in
intermittent or complete failure to sense and/or pace.
----
Seizure Actions Filed:
Product: Hot Sauce (91-661-261).
Charge: Adulterated - Product contained in swollen cans.
Firm: La Hacienda Imports, Chicago, Illinois.
Filed: October 23, 1991 - U.S. District Court for the Northern
District of Illinois; Eastern Division; Civil #91C6741,
FDC #66306.
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